CAJ | 학술논문

目的：制备盐酸地尔硫卓缓释脉冲控释微丸胶囊。方法：采用丙烯酸树脂域号和微晶纤维素( MCC)为骨架材料制备盐酸地尔硫卓缓释微丸；采用低取代羟丙基纤维素( Low Substituted Hydroxypropylcellulose L-HPC)为内层溶胀材料,选用乙基纤维素水分散体( Surelease)为外层控释材料制备脉冲微丸。将两种微丸混合后制成缓释脉冲微丸胶囊,同时考察体外溶出度的影响因素。结果：体外释放试验证明,缓释微丸体外12h可持续释12h,脉冲微丸体外可达到时滞为4h,滞后1.5 h,累积释药80%以上的脉冲释药效果。两种微丸按比例混合后,其释药机制符合一级释药模型,达到良好的混合释放效果。结论：该制剂具有良好的缓释与脉冲效果。
목적：제비염산지이류탁완석맥충공석미환효낭。방법：채용병희산수지역호화미정섬유소( MCC)위골가재료제비염산지이류탁완석미환；채용저취대간병기섬유소( Low Substituted Hydroxypropylcellulose L-HPC)위내층용창재료,선용을기섬유소수분산체( Surelease)위외층공석재료제비맥충미환。장량충미환혼합후제성완석맥충미환효낭,동시고찰체외용출도적영향인소。결과：체외석방시험증명,완석미환체외12h가지속석12h,맥충미환체외가체도시체위4h,체후1.5 h,루적석약80%이상적맥충석약효과。량충미환안비례혼합후,기석약궤제부합일급석약모형,체도량호적혼합석방효과。결론：해제제구유량호적완석여맥충효과。
Objective:To study the preparation of sustained-release and pulsatile pelletsof Diltiazem Hydrochloride ( DIL ) . Methods:To preparation sustained-release solid dispersion of DIL with acrylic resinIIand MCC;The cores of pulstile pellets were prepared by extrusion-spheronization and coated with low-substitued hydroxypropylcellulose ( L-HPC ) as the inner swelling layer and ethylcellulose aqueous dispersion ( Surelease ) as the outer controlled layer. The two kinds of pellets mixed to preparation Sustained-release and Pulsatile Pellets. Results:The sustained-release pellets can release to 12h;The pulstile release pellets,with a lag time of 4h and more than 80% released within following 1. 5h under the simulated gastro-intestinal pH conditons. To mixed two kinds of pelltes can meet the requirements of preparation. Conclusion:The pellets have an ideal sustained-release and pulsatile release.